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Bayer's Yaz May Face More Labeling Changes On Blood Clot Warnings

This article was originally published in The Pink Sheet Daily

Executive Summary

The combination oral contraceptive's warnings were updated in March, but two recently published epidemiological studies that found a higher risk of venous thromboembolic events with drospirenone compared to levonorgestrel could result in another labeling revision.

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FDA will seek advisory committee input Dec. 8 on whether and how to adjust labeling and to conduct further studies for contraceptives containing progestin drospirenone because of the drugs’ potential risk for venus thrombotic and thromboembolic events. The agency has a specific study design in mind that it wants sponsors to conduct.

Blood Clot Risks For Yasmin, Yaz, Ortho Evra Get Panel Review After FDA Epidemiology Study

FDA's Reproductive Health Drugs and Drug Safety and Risk Management advisory committees will discuss the benefits and risks of drospirenone-containing drugs and the Ortho Evra patch at a two-day meeting in December.

Blood Clot Risks For Yasmin, Yaz, Ortho Evra Get Panel Review After FDA Epidemiology Study

FDA's Reproductive Health Drugs and Drug Safety and Risk Management advisory committees will discuss the benefits and risks of drospirenone-containing drugs and the Ortho Evra patch at a two-day meeting in December.

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